GSP Neonatal Total Galactose kit

Basic Information

• Brand Name: GSP Neonatal Total Galactose kit
• Primary DI: 06438147367917
• Version / Model: 3309-002U
• Catalog Number: 3309-002U
• Company Name: Wallac Oy
• Labeler DUNS: 540156544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-04
• Public Version: 1
• Public Version Date: 2021-06-14
• Public Version Status: New
• Public Device Record Key: 0ba67f14-b1a3-4784-ac1e-b003aeb99b73

Device Description

For the quantitative determination of total galactose concentration in dried blood. Note: Kit contains multiple packages.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JIA	Enzymatic Methods, Galactose	Clinical Chemistry	862.1310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59372	Total galactose IVD, kit, enzyme fluorescence	A collection of reagents and other associated materials intended to be used for the quantitative measurement of total galactose (galactose and galactose-1-phosphate) in a clinical specimen, using an enzyme fluorescent method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438147367917	GS1

Premarket Submissions

Submission Number	Supplement Number
K190335	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -30 – -16 Degrees Celsius